PRIME II is a natural successor to PRIME I, with similar eligibility criteria (see below). Patients are randomised to receive or not receive adjuvant radiotherapy, following breast conserving surgery and endocrine therapy. The recruitment target is 1300 patients, with a projected closure date of 30th November 2009.
The principal endpoints for this second phase of the trial are ipsilateral breast recurrence rates, regional recurrence rates, contralateral recurrence, distant metastases, disease-free survival, and overall survival.
Currently, there are 95 centres participating in the trial, including centres from Greece, Belgrade, Yugoslavia, and Malta, and two from Australia. For a complete list of participating centres, please click here.
|Recruitment is well underway, with 1270 randomised directly into PRIME II. Following Ethics approval and further funding from the Scottish Government and the Breast Cancer Institute, our new target for patients recruited directly into PRIME II is 1306.|
A copy of the protocol in Adobe Acrobat format can be found here. If you would prefer a paper copy, please contact the Trial Administrator. Copies of the documentation and Site Specific Assessment forms can be found on the downloads page.